Consultants Specializing in Regulatory Affairs for FDA Compliance

For more information on our regulatory services please click on one of the links below.

510(k) Submission (Premarket Notification)

1. Experience

Our consultants have over 100-years of FDA regulatory and sales/marketing backgrounds and business ownership. We understand not only the regulatory side of your submission but also the marketing side. We understand the financial pressures placed on all businesses when trying to comply with FDA regulatory requirements and the costs of having to perform expensive testing in order to demonstrate the safety and effectiveness of your device to that of your predicate device. At the end of the 510k process, it is important to insure your cleared marketing claims provide your salesforce or distributors the necessary sales claims to be competitive.

Smith Associates has over 280 successful 510(k) clearances across all CDRH reviewing Branches. View all 510(k) clearances.

2. Fixed Fee- Controlling your Budget

We understand that submitting a 510(k) can be costly and in some cases crippling due to FDA’s requirements for sterility validation, package integrity studies, shelf life studies, accelerated aging studies, biocompatibility tests, EMC and general electrical safety tests, performance tests, comparative bench tests, human factor studies, and in some cases clinical studies.

Because we are business people like you, we instituted a FIXED FEE for our consulting services that hopefully will meet your budgetary needs. Our FIXED FEE requires 50% payment to start the project and the remaining 50% is due prior to us hand-delivering your submission to the FDA Document Center in Silver Spring, Maryland. There will be NO ADDITIONAL FEES for our consulting services, as they relate to your 510(k) submission, which equals NO SURPRISES. Please contact us for a quote for your submission.

3. Product Classification – and subsequent regulatory burden

The first steps in product development (concept and feasibility) are determining if there is a market for your product, can your product achieve its’ financial objectives and what are the regulatory burdens for achieving FDA 510(k) or PMA clearance.

It is just as important for Smith Associates, as it is for you, to determine if we are the right consulting firm to assist you through the FDA clearance process. Smith Associates provides FREE product classification, product code and quality system requirements for your medical device.

4. Location – Interactive Deficiency Response

Smith Associates is located 20 minutes from the FDA. All of our submissions and responses are hand delivered to and date-stamped by the Document Room. The FDA has changed their rules on review time with second responses moving to an interactive review resulting in mere days or sometimes hours to respond to FDA’s questions. We can handle your active reviews by being not only in the same time zone but in the same area.

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